Cardio Notes: Rivaroxaban Safety; Post-MI Drug Use

The safety of rivaroxaban (Xarelto) in new users with atrial fibrillation will be examined, and both racial/ethnic and sex disparities continue to be seen in the use of preventive drugs after an acute myocardial infarction (MI).

FDA Eyes Rivaroxaban Safety

The FDA will be taking a closer look at the safety of rivaroxaban (Xarelto) when used for stroke prevention in atrial fibrillation.

A new prospective surveillance study run through the agency's Mini-Sentinel pilot project was announced on Jan. 13, and public comments will be accepted through Jan. 27. The analysis will track select safety outcomes -- including ischemic stroke, intracranial hemorrhage, and gastrointestinal bleeding -- in adults with atrial fibrillation who are starting the drug for the first time. The outcomes will be compared with warfarin users.

The protocol -- similar to the one attached to an analysis of dabigatran (Pradaxa) that was announced at the end of December -- noted that "the fact that FDA requests and receives data on a particular product through Mini-Sentinel does not necessarily mean there is a safety issue with the product."

Gang Fang, PharmD, PhD, of the University of North Carolina at Chapel Hill, and colleagues analyzed data from about 85,000 Medicare Part D beneficiaries who survived at least 30 days after an acute MI. At 30 days, there were differences by race/ethnicity in the use of post-MI therapies, although women had lower rates of use of ACE inhibitors/angiotensin receptor blockers and beta-blockers compared with men.

More differences emerged by 1 year, however. Compared with white men, Hispanic and black women were the least likely to be adherent to the preventive therapies, followed by women from other racial/ethnic groups and black and Hispanic men.

"This study demonstrates that despite remarkable progress in eliminating gaps in initiation of treatment by elderly racial/ethnic and gender groups following acute MI, considerable differences in continuing care, such as medication adherence, still strongly persists," the authors wrote.

Imprisonment May Harm Family's Heart Health

Having a family member behind bars appears to weigh heavily on the hearts of those on the outside, especially women, according to a study in the American Journal of Public Health.

Hedwig Lee, PhD, of the University of Washington in Seattle, and colleagues looked at data on nearly 5,500 black and white adults who took part in the National Survey of American Life. They examined the association between having an incarcerated family member and five self-reported conditions, including diabetes, hypertension, heart attack or stroke, obesity, and fair or poor health.

Before accounting for other factors, having an incarcerated family member was associated with an increased likelihood of all five conditions, but only for women. In adjusted analyses, the associations remained significant for obesity (rate ratio 1.44), heart attack of stroke (RR 2.53), and fair or poor health (RR 1.93).

Incarceration of a family member "should be considered a unique risk factor that contributes to racial disparities in health," the authors wrote. "Family member incarceration may lead to racial disparities in physical health among women because of the disproportionate experiences of this stressful life event among black women."

Remote ICD Monitoring Saves Money

New findings from the ECOST study released by Biotronik showed that home monitoring of patients with implantable cardioverter-defibrillators (ICDs) with the company's system reduced the cost of follow-up within the French National Health Insurance system.

Previous findings from the trial demonstrated that home monitoring with the Biotronik system -- versus standard in-office care -- led to a 52% reduction in the percentage of patients with inappropriate shocks and a 72% cut in the risk of hospitalization related to inappropriate shocks.

The new cost analysis indicated that over 27 months of follow-up, ambulatory costs, but not hospital costs, were lower with remote monitoring. After adding the costs of the device, the ambulatory costs, and the costs of the remote monitoring services, there was still a reported savings of about 315 Euros (U.S.$426) per patient per year.

The study did not take into account the physician fees for remote monitoring because they're not reimbursed by the French system, but Biotronik said that the savings identified in the study should be used for physician reimbursement.

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